Long Term Results of Elevate Apical and Posterior for Vaginal Wall Prolapse Repair

To assess the safety, efficacy and impact on quality of life of the Elevate Apical and Posterior (EAP) (AMS, MN, USA). Prospective, multi-center study. Ten US and 6 EU urogynecologic, urologic and gynaecologic sites. Women with posterior vaginal prolapse (≥ Stage II) and/or apical (cuff or cervix) descent (≥ Stage II) were enrolled. Subjects received EAP with IntePro™ Lite (Type I polypropylene mesh) inserted transvaginally without trocars into the rectovaginal space, affixed to the sacrospinous ligaments bilaterally. Primary endpoint was the percent of subjects with Stage≤I (“cure”) at follow-up using the Last Failure Carried Forward method. Secondary endpoints included, adverse events (AE's), validated quality of life questionnaires, and patient satisfaction. Statistical significance was defined by P< 0.05. One hundred thirty-nine patients were implanted, with a mean age of 62.5±11.6 years. Two-year follow-up data were available for 113 (81.3%). Apical and posterior “cure” was seen in 88.2% (30/34) and 91.5% (97/106) of subjects, respectively. Of the 13 who exhibited anatomic failure, only 4 complained of bulge symptoms. Mesh exposure was reported in 7.9% (11/139) of patients, with 3 requiring mesh revision in the operating room. No device explants were performed. Most common AE's (> 1%) included constipation (2.2%), pain or discomfort in the buttock (2.2%), hematoma (1.4%), vaginal infection (1.4%), UTI (1.4%), and superficial wound dehiscence without extrusion (1.4%). Significant improvement was seen in all Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire subscales. An increase in the mean Pelvic Organ Prolapse Urinary Incontinence Sexual Function Questionnaire score was recorded, however, improvement was not statistically significant. Patient satisfaction was such that 91.2% felt that they were “some” or “a lot” improved, and 88.5% were “moderately”, “very”, or “extremely” satisfied. The single-incision EAP was shown to provide long term safety and effectiveness.